Medical Diagnostics

Japan Approves Sarclisa-VRd for Newly Diagnosed Multiple Myeloma Patients

Regulatory green light follows IMROZ Phase 3 study results showing significant progression-free survival benefit...

Meril Expands Cardiovascular Portfolio in India and Beyond with Cutting-Edge Surgical Solutions

Indian MedTech leader Meril introduces a new range of advanced cardiovascular surgical products, including biomechanically engineered valves, high-performance sutures, and precision-driven cardiac needles, reinforcing its commitment to clinical excellence and patient safety. ...

IceCure Medical Seeks Israeli Regulatory Approval for Next-Gen XSense™ Cryoablation System

Building on FDA clearance, IceCure files for Israeli approval of its XSense™ System, expanding minimally invasive cryoablation solutions across multiple medical specialties in line with the growing trend of surgical de-escalation. ...

Immunovia to Appoint New CFO as Company Shifts Focus to U.S. Market

With plans to commercialize its pancreatic cancer test in the U.S. by late 2025, Immunovia seeks financial leadership with diagnostics expertise and global capital market experience....

Co-Diagnostics Withdraws 510(k) Submission for COVID-19 Test to Pursue Enhanced Version

Following constructive discussions with the FDA, Co-Dx shifts focus to an improved test submission, incorporating platform advancements and optimizing long-term performance....

Ginkgo Bioworks Secures €24M EU Grant to Develop Rapid Next-Gen Sequencing for Respiratory Diagnostics

In collaboration with HaDEA and HERA, Ginkgo leads the RANGER project to create a point-of-care metagenomic sequencing device, aiming for 6-hour turnaround diagnostics to revolutionize pandemic preparedness and hospital triage across Europe. ...

UroMems Achieves Major Milestone in First-Ever Smart Implant Study for Female SUI Patientsv

With all female patients in its groundbreaking clinical feasibility study reaching six-month primary endpoints, UroMems' UroActive System marks a transformative step in treating stress urinary incontinence. The AI-powered smart implant, designed to enhance patient quality of life, is now paving the way for expanded adoption in the U.S. and Europe. ...

3Shape Celebrates 25 Years of Innovation with AI-Powered Advancements in Dental CAD Workflows

3Shape is celebrating 25 years of innovation by introducing a paradigm shift in CAD workflows for dental labs with the upcoming release of 3Shape Dental System 2024. This new software update will include a free AI-driven crown design application along with several workflow enhancements to significantly improve efficiency and digitization for dental labs. As the first employee hired at 3Shape 25 years ago, Rune Fisker, Senior Vice President of Product Strategy, reflects on the remarkable evolu...

South Korea’s PranaQ Secures FDA Clearance for AI-Powered Sleep Apnea Wearable, Backed by NAVER D2SF

With FDA 510(k) clearance for TipTraQ, PranaQ is set to transform home-based sleep diagnostics. The AI-driven wearable, supported by NAVER D2SF, delivers clinical-grade sleep and respiratory insights, ensuring accessible, multi-night testing and seamless remote monitoring. With FDA 510(k) clearance for TipTraQ, PranaQ is set to transform home-based sleep diagnostics. The AI-driven wearable, supported by NAVER D2SF, delivers clinical-grade sleep and respiratory insights, ensuring a...

Encore Clinical Holdings Expands Wound Care Services to Tennessee, Strengthening Leadership in Specialized Care

With its innovative, technology-driven model, Encore Wound Care extends its footprint to Tennessee, enhancing clinical outcomes, optimizing facility operations, and treating over 10,000 wounds per week across its growing service regions....